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Most of the FDA's funding comes from user fees, not taxpayers, and the agency is stretching its budget by reducing travel and training expenses, Commissioner Dr. Margaret Hamburg told a Senate panel. Sequestration cut FDA funding by $209 million, including $83 million in user fees already negotiated with the drug industry.

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BioMerieux unit BioFire has filed a de novo submission with the FDA for its FilmArray Meningitis/Encephalitis Panel. The clinical diagnostic panel, which runs on the FilmArray molecular testing platform, is used for testing cerebrospinal fluid for common fungi, viruses and bacteria that cause encephalitis or meningitis outside of health care settings.

The FDA and state health regulators called for congressional action to bolster federal oversight of drug compounders as Congress prepared for hearings on a meningitis outbreak tied to the New England Compounding Center. "It is clear that the patchwork of disparate state regulations is not enough to keep the public safe," Massachusetts Department of Public Health interim Commissioner Dr. Lauren Smith wrote in prepared testimony filed with a House oversight panel. "FDA's authority over compounding pharmacies is more limited by law and needs to be strengthened," the FDA said. FDA Commissioner Dr. Margaret Hamburg is set to testify today.

A bipartisan group of senators is supporting an amendment to the Prescription Drug User Fee Act that would put a moratorium on the agency's ability to regulate health care applications as medical devices. The HHS health IT certification program is a better venue than the FDA's premarket approval process for regulating the use of computers in health care, write former FDA Deputy Commissioner Scott Gottlieb and health information entrepreneur J.D. Kleinke, who are fellows of the American Enterprise Institute.

If the price is right, Tellabs will look at making acquisitions to grow its business, according to CEO Rob Pullen. "I don't mind using our strong balance sheet to invest for the long term," Pullen said in an interview in which he also spelled out the reasons for abandoning its custom GPON project with Verizon Communications, as well as the company's focus on "backhaul, optical networks and service delivery."

Many Americans have become flummoxed in these budget-conscious times by the attempt to determine time- versus cost-savings while shopping, as well as what discounted items are truly necessities. One expert says Americans are making "diagnostic errors." "They're stressed out, and using the wrong information to make a decision, and ignoring all other data that contradicts that decision," he said.